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IRCT20090813002342N10 IRCT 2020-09-05 Mazandaran University of Medical Sciences Effect of dexmedetomedine and fentanyl in venous catheter placement Comparison of efficacy and safety between dexmedetomedine and fentanyl for central venous catheter placement in pediatric intensive care unit (PICU) 2020-07-07 anticipated 54 Complete https://irct.ir/trial/49736 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By simple randomization, individuals who meet the inclusion criteria and have completed informed consent will be assigned to two groups. This is done by assigning a random number to each person entering the study with random number generation software (using www.random.org). If it is an odd number, the patient will be allocated in group 1 and if it is even the patient will be assigned to group 2. The randomization process is performed by the ward supervisor (who is independent of the principal investigators). Randomization is performed before a patient enters the study and then the intervention is assigned according to his or her group therapy, Blinding description: If a central catheter is needed, it will be announced by the treating physician. he trained nurse prepares dexmedetomidine and fentanyl according to the random code obtained (individual or even), respectively. The nurse, knowing the type of medicine, provides it to the doctor after diluting and homogenizing it in the same syringe. The physician performs the catheterization without knowing the type of drug, and the outcome assessor evaluates and records the sedation-related indicators under the physician's supervision. After completing the procedure and recording the outcomes (maximum 0.5-1 hour), the type of drug used is determined and recorded in the patient's file. 3 Sedation in children for placement of a central venous catheter. Intervention 1: Intervention group: Children receiving dexmedetomidine for placement of central venous catheter. Patients in this group receive dexmedetomidine intravenously at a dose of 1 mcg/kg for 10 minutes as a loading dose. Then during the catheter placement (nearly 0.5-1 hour), the infusion of these drugs is continued at a rate of 1 mcg/kg/hr. If sedation is insufficient (Ramsay Sedation Scale <4), the loading dose is repeated and the dose of drug infusion is doubled. In case of insufficient sedation for each patient, intravenous propofol is used at a dose of one mg per kg of body weight. Intervention 2: Control group: Children receiving fentanyl for placement of central venous catheter. Patients in this group receive fentanyl intravenously at a dose of 1 mcg/kg for 10 minutes as a loading dose. Then during the catheter placement (nearly 0.5-1 hour), the infusion of these drugs is continued at a rate of 1 mcg/kg/hr. If sedation is insufficient (Ramsay Sedation Scale <4), the loading dose is repeated and the dose of drug infusion is doubled. In case of insufficient sedation for each patient, intravenous propofol is used at a dose of one mg per kg of body weight. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Access period starts 6 months after the results are published To whom: Researchers in academic and scientific institutions Conditions: For information on the details of the study without doing new statistical analysis Where to obtain: Sending an email to mrrafati@mazums.ac.ir How to obtain: The email will be checked if the request is clear and the information conditions are met Information is sent. Comments:
public Mohamadreza rafati
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd.
Sari Iran (Islamic Republic of) 4815733971 +98 15 1223 3014 mrrafati@mazums.ac.ir Mazandaran University of Medical Sciences scientific Mohammadreza Rafati
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd
Sari Iran (Islamic Republic of) 4815733971 +98 15 1223 3014 mrrafati@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Children one month to 18 years old who need a central venous catheter placement enter to study 1 month 18 years Both bradycardia hypertension above 99% apnea before the study cardiac conduction impairment in the ECG before drug administration patients with ASA physical status classification IV renal failure known heart failure history of heart surgery shock Z45.2 Encounter for adjustment and management of vascular access device Treatment - Drugs Treatment - Drugs Intervention group: Children receiving dexmedetomidine for placement of central venous catheter. Patients in this group receive dexmedetomidine intravenously at a dose of 1 mcg/kg for 10 minutes as a loading dose. Then during the catheter placement (nearly 0.5-1 hour), the infusion of these drugs is continued at a rate of 1 mcg/kg/hr. If sedation is insufficient (Ramsay Sedation Scale <4), the loading dose is repeated and the dose of drug infusion is doubled. In case of insufficient sedation for each patient, intravenous propofol is used at a dose of one mg per kg of body weight. Control group: Children receiving fentanyl for placement of central venous catheter. Patients in this group receive fentanyl intravenously at a dose of 1 mcg/kg for 10 minutes as a loading dose. Then during the catheter placement (nearly 0.5-1 hour), the infusion of these drugs is continued at a rate of 1 mcg/kg/hr. If sedation is insufficient (Ramsay Sedation Scale <4), the loading dose is repeated and the dose of drug infusion is doubled. In case of insufficient sedation for each patient, intravenous propofol is used at a dose of one mg per kg of body weight. Adequate sedation following the use of dexmedetomedine or fentanyl for central venous catheter placement. Timepoint: Before and at the end of the administration of the drug loading dose and then every 5 minutes until the end of catheter placement. Method of measurement: Ramsay Sedation Scale. Blood pressure. Timepoint: Before and at the end of drug loading dose, then every 5 minutes until the end of catheter placement. Method of measurement: By digital monitoring device in PICU. Heart rate. Timepoint: Before and at the end of drug loading dose, then every 5 minutes until the end of catheter placement. Method of measurement: By digital monitoring device in PICU. Respiratory rate. Timepoint: Before and at the end of drug loading dose, then every 5 minutes until the end of catheter placement. Method of measurement: By digital monitoring device in PICU. O2 saturation. Timepoint: Before and at the end of drug loading dose, then every 5 minutes until the end of catheter placement. Method of measurement: By digital monitoring device in PICU. Mazandaran University of Medical Sciences Approved 2020-07-07 Ethics Committee of Mazandaran University of Medical Sciences Payambar Azam Complex, 18 Km Farah Abad Blvd., Khazar Square, Sari, Mazandaran Province Sari Mazandaran Iran (Islamic Republic of)